RecruitingNCT06314646

Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients

Postoperative and Long-term Outcomes of Transanal Tran-section and Single-stapled Anastomosis (TTSS) in Rectal Can-cer Patients: a Multicentric International IDEAL Stage 2b Prospective Parallel Cohort Study


Sponsor

Istituto Clinico Humanitas

Enrollment

472 participants

Start Date

Mar 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches.
  • Patients scheduled for open, laparoscopic, or robotic surgery.
  • Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma.

Exclusion Criteria3

  • Immediate or delayed hand-sewn coloanal anastomosis.
  • Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
  • Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.

Interventions

PROCEDURETransanal Transection and Single-Stapled anastomosis (TTSS)

Low anterior rectal resection with Transanal Transection and Single-Stapled anastomosis (TTSS)

PROCEDUREDouble-stapled Total Mesorectal Excision (TME)

Low anterior rectal resection with double-stapled Total Mesorectal Excision (TME)


Locations(1)

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

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NCT06314646


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